RESULTS OF LEAD CLINICAL TRIAL IN INTERMEDIATE AMD

INVESTOR PRESENTATION

TOM SPURLING, CHRIS BAKER

21 SEPTEMEBER 2018

DISCLAIMER

This presentation has been prepared by Ellex Medical (Ellex, ELX: ASX). While the information in this presentation hasbeen prepared in good faith and with reasonable care, no representation or warranty, express or implied, is made as tothe accuracy, adequacy or reliability of any statement, estimates, opinions or other information contained in thepresentation. This presentation may contain forward looking statement. These forward-looking statement have been madebased upon Ellex’s expectations and beliefs concerning future developments and their potential effect on Ellex (and it’scontrolled entities) and are subject to risks and uncertainty which are, in many instances, beyond Ellex’s control. Noassurance is given that future developments will be in accordance with Ellex’s expectations. Actual results could differmaterially from those expected by Ellex. This presentation does not constitute an offer to sell or a solicitation of an offer topurchase any security or financial product or service. Any such offer or solicitation shall be made only pursuant to aProduct Disclosure Statement, Information Memorandum, Prospectus or other offer document relating to a financialproduct or service. Past performance is not necessarily indicative of future results and no person guarantees theperformance of any financial product or service or the amount or timing of any return from it. There can be no assurancethat the financial product or service will achieve any targeted return, that asset allocations will be met or that the financialproduct or service will be able to implement its investment strategy and investment approach or achieve its investmentobjective. The information contained in this presentation is not intended to be relied upon as advice to investors orpotential investors, who should consider seeking independent professional advice depending upon their specificinvestment objectives, financial situation or particular needs.

L E A D C L I N I C A L T R I A L : A S X E L X2

• Overview of LEAD Clinical Trial

• Overview of Intermediate Age-related Macular Degeneration (iAMD)

• Overview of Ellex 2RT® Therapy

• Key Results from LEAD contained in Ophthalmology Scientific Publication

• Trial Conclusions

• Market Dynamics and Commercial Opportunity

• Q&A

Contents

L E A D C L I N I C A L T R I A L : A S X E L X3

1 Guymer RH, et al. Sub-Threshold Nanosecond Laser Intervention in Age-Related Macular Degeneration: The LEAD Randomized Controlled Clinical Trial. Ophthalmol 2018; In press2 OCT – optical coherence tomography; NIR- near infrared imaging; FAF – fundus autofluorescence; CFP - colour fundus photography 3 Guymer RH, et al. Nanosecond-laser application in intermediate AMD: 12-month results of fundus appearance and macular function. Clin Exp Ophthalmol 2014; 42(5): 466-79

Overview of LEAD Clinical Trial

• Double-masked, randomised, sham-controlled trial over 36 months in 292 patients with iAMD across six sites with 1:1 randomisation to Ellex 2RT® or sham treatment received at six monthly intervals1

• Primary endpoint – progression to advanced AMD in treated eye of Ellex 2RT® pts versus sham patients

• Secondary endpoints – safety, change in drusen volume and visual function, progression to advanced AMD innon-study eye

• Sub Group – post hoc analysis on patients without coexistent reticular pseudodrusen (RPD) deposits representing 76% of enrolled patients versus 24% with RPD at baseline

L E A D C L I N I C A L T R I A L : A S X E L X4

The LEAD trial has validated the safety and efficacy of Ellex 2RT® as an intervention for many people with intermediate AMD.

• Largest ever randomised study conducted in iAMDpatients with a non-thermal, non-invasive pulse laser intervention

• First randomised study in iAMD to utilise modern multi-modal imaging (MMI) techniques to detect and define AMD and greater power to detect treatment effects (e.g. OCT, NIR, FAF and CFP)2

• Rationally designed following successful pilot study in 50 patients published in 20133

AMD (“Age-Related Macular Degeneration”):

• leading cause of blindness in the developed world

• affects one in seven Australians over the age of 501

Unmet need: late stage AMD is treated with 6 weekly injections of drugs directly into a patient’s eye. This can help to preserves vision, but long-term people lose vision due to scarring. Further:

• onerous on patients and caregivers, and;• burden for government health schemes to

purchase the drugs

1. Macular Disease Foundation, Access Economics

Overview of iAMD

L E A D C L I N I C A L T R I A L : A S X E L X5

iAMD AND THE LEAD TRIAL• One of the goals of the LEAD

trial was to examine whetherEllex 2RT® could delay iAMD to more advanced forms of the disease, where retinal function declines markedly and vision becomes impaired.

• Treatments for late AMD are limited to regular injections ofanti-VEGF drugs to the back of the eye.

HEALTH

OF R

ETINA &

MAC

ULA

TIME IN YEARSt175 years of age

Injection in eyeRequiring anti-VEGF injection into eye to prevent severe vision loss

Disease progression without Ellex 2RT®

Defer injection in eye

Good/Normal

Ellex 2RT® to slow disease progression

Apply Ellex 2RT®

nanopulse laser light therapy

Indication of retinal health failing, as shown in retinal imaging

Detection

L E A D C L I N I C A L T R I A L : A S X E L X6

• Specially designed rapid nanosecond pulse, non-thermal laser intervention targeting selected retinal pigment epithelium (RPE) cells to promote extracellular repair mechanism and rejuvenation of the retina

• Technology underpinned by a significant patent portfolio until 2035

• CE Mark for Diabetic Macular Edema (DME) in 2012 and early AMD in 2014

• FDA Clearance for Clinically Significant Macular Edema (CSME) in 2013

• Limited installed base to date; clinicians awaiting further clinical evidence from LEAD trial

• First of Ellex’s laser platforms to incorporate per procedure fee software

Overview of Ellex 2RT®

L E A D C L I N I C A L T R I A L : A S X E L X7

Ellex 2RT® is Ellex’s proprietary, patented laser therapy that stimulates the eye's natural healing response to treat the early stages of AMD.

ELLEX 2RT® LASER

• 79.6% of patients assessed were randomised into trial

• Intent-to-Treat (ITT) analysis on 292 patients

• Protocol deviations/lost to follow up of 14% in sham group versus 19% in 2RT® treatment group

• Per protocol (PP) analysis on 243 patients

Consort Diagram

L E A D C L I N I C A L T R I A L : A S X E L X8

Assessed for eligibility (n=367)

Excluded (n=75)Did no meet inclusion criteria (n=48)Declined to participate (n=4)Other reasons (n=23)

Randomised (n=292)

Allocated to sham (n=145)

Included in ITT analysis (n=145)

Lost to follow-up (n=8)Death (n=3)Consent withdrawn (n=4)Co-morbidity (n=1)

Clinically significant protocol deviation (n=13)

Included in PP analysis (n=124)

Allocated to sub-threshold nanosecond laser (n=147)

Included in ITT analysis (n=147)

Lost to follow-up (n=10)Death (n=2)Consent withdrawn (n=7)Co-morbidity (n=1)

Clinically significant protocol deviation (n=18)

Included in PP analysis (n=119)

Allocation

Intention to treat (ITT) analysis

Per protocol (PP) analysis

Enrollment

1 Lek JJ et al. Subthreshold Nanosecond Laser Intervention in Intermediate Age-Related Macular Degeneration: Study Design and Baseline Characteristics of the Laser in Early Stages of Age-Related Macular Degeneration Study (Report Number 1). Ophthalmology Retina 2017

• Patient baseline demographics and baseline ocular characteristics were well balanced between the two ITT arms

• No significant difference in each of the baseline characteristics noted (p>0.05), with exception of Lutein-Vision intake higher in sham treatment arm1

Prof. to provide high res copy]Patient Baseline Characteristics

L E A D C L I N I C A L T R I A L : A S X E L X9 SNL treatment

(n=147)

Sham treatment

(n=145)

Demographics

Age (years) 70·3 (7·0) 69·8 (8·1)

Sex (female) 103 (70·1%) 112 (77·2%)

Ethnicity (Anglo-Saxon) 134 (91·2%) 128 (88·3%)

Smoking history

Never 77 (52·4%) 77 (53·1%)

Past or current 70 (47·6%) 68 (46·9%)

Macu-Vision®* intake (yes) 50 (34·0%) 45 (31·0%)

Lutein-Vision®# intake (yes) 9 (6·1%) 24 (16·6%)

Study eye ocular characteristics

BCVA (number of letters) 83 [80, 87] 84 [79, 88]

Pigmentary abnormalities

Definitely present 46 (31·3%) 51 (35·2%)

Absent or questionable 101 (68·7%) 94 (64·8%)

Reticular pseudodrusen

Definitely present 35 (23·8%) 35 (24·1%)

Absent or questionable 112 (76·2%) 110 (75·9%)

Data are frequency (%), mean (standard deviation) or median [25th to 75th

percentile]. SNL = sub-threshold nanosecond laser. BCVA = best-corrected visual

acuity. * = active ingredients of Macu-Vision® include Vitamin C, Vitamin E, zinc

oxide, cupric oxide. # = active ingredients of Lutein-Vision® include Lutein,

Selenomethionine, Zeaxanthin, omega-3 triglycerides-fish oil.

Table 1: Demographics and baseline ocular characteristics

SNL treatment

(n=147)

Sham treatment

(n=145)

Definitely related ocular adverse events

Participants reporting one or more adverse events 15 (10·2%) 1 (0·7%)

After-images* 5 (3·4%) 1 (0·7%)

Retinal haemorrhage 10 (6·8%) 0 (0·0%)

Possibly related ocular adverse events

Participants reporting one or more adverse events 25 (17·0%) 24 (16·6%)

Epiretinal membrane 1 (0·7%) 4 (2·8%)

Symptomatic PVD or floaters 8 (5·4%) 5 (3·4%)

Ocular discomfort following treatment 7 (4·8%) 11 (7·6%)

Cataract requiring surgery 3 (2·0%) 2 (1·4%)

Other 3 (2·0%) 5 (3·4%)

Other adverse events

Unrelated ocular adverse events 81 (55·1%) 70 (48·3%)

Non-ocular adverse events 103 (70·1%) 109 (75·2%)

Serious adverse events

Participants reporting one or more serious adverse events 56 (38·1%) 50 (34·5%)

Cardiovascular or cerebrovascular disorders 14 (9·5%) 13 (9·0%)

Death (unknown cause) 0 (0·0%) 1 (0·7%)

Infections 8 (5·4%) 2 (1·4%)

Injury and procedural complications 10 (6·8%) 9 (6·2%)

Neoplasms (benign and malignant) 7 (4·8%) 8 (5·5%)

Nervous system disorder 3 (2·0%) 3 (2·1%)

Respiratory disorder 5 (3·4%) 3 (2·1%)

Surgery and medical procedures 7 (4·8%) 5 (3·4%)

Other (medical) 23 (15·6%) 22 (15·2%)

Data are number of participants (%). PVD = posterior vitreous detachment. * = visible for more than one day, as

reported at the one-week phone call after the initial treatment.

Table 2: Number and proportion of patients with adverse events

• Ellex 2RT® was well tolerated with no statistically significant difference in Serious Adverse Events (SAEs) reported

• Ocular Adverse Events (AEs) with Ellex 2RT® were retinal haemorrhages that resolved in all cases without any untoward sequelae

• All other adverse events recorded were statistically no different between the Ellex 2RT® treatment group and sham group

• 3.4% of patients reported after-images >1 day after treatment

• No difference between the groups in events unrelated to the progression to late AMD

Safety

L E A D C L I N I C A L T R I A L : A S X E L X10

PER PROTOCOL (PP)• No significant difference in

progression to late AMD under ITT analysis (p=0.122) or the PP analysis (p=0.092)

• At 36 months, 13.6% progressed to late AMD in the 2RT® treatment group versus 17.2% in the sham eye (ITT)

• At 36 months, 15.1% progressed to late AMD in the 2RT® treatment group versus 20.2% in sham eye (PP)

• Non-significant trend in favour of the 2RT® treatment group

* Adjusted Hazard Ratio (HR) - The potential confounders of baseline age (as a continuous measure), sex, intake of Lutein-Vision® or Macu-Vision® at baseline (yes vs. no for each), presence of RPD and pigmentary abnormalities (definitely present vs. absent/questionable) were additionally included as covariates in a fully adjusted model as specified a priori

Primary Endpoint Results

L E A D C L I N I C A L T R I A L : A S X E L X11

INTENT TO TREAT (ITT)

Number at risk

Sham 145 143 137 128 127 120 117SNL 147 145 140 133 128 123 119

Time from baseline (months)

Cu

mu

lati

ve

pro

po

rtio

n

Adjusted HR: 0·61(95% CI 0·33–1·14)

SNLSham

• Estimated effect on Forest plot of 2RT®

examining the two phenotypes of late AMD (neovascular AMD and drusen-associated atrophy)

• Pronounced treatment effect on drusen-associated atrophy favouring 2RT®

(HR=0.53)

Treatment Effect on Late AMD

L E A D C L I N I C A L T R I A L : A S X E L X12

0·12 0·25 0·5 1 2 4 8

Favours SNL Favours sham

Events / Total

Endpoint SNL Sham

Intention-to-treat (n = 292)

Late AMD 20/147 25/145

Neovascular AMD 7/147 5/145

Drusen-associated atrophy 13/147 20/145

Per-protocol (n = 243)

Late AMD 18/119 25/124

Neovascular AMD 7/119 5/124

Drusen-associated atrophy 11/119 20/124

Adjusted Hazard

Ratio (95% CI)

0·61 (0·33–1·14)

1·21 (0·37–3·93)

0·53 (0·25–1·13)

0·56 (0·29–1·10)

1·24 (0·37–4·17)

0·49 (0·21–1·12)

• A clinically meaningful 77% reduction in the risk of progression (HR=0.23) in patients who received 2RT® versus sham

• 2RT® showed a significant treatment effect in this patient population (p=0.002)

• RPD is a key biomarker of retinal pigment epithelium (RPE) dysfunction and has a high association with progression to late-stage AMD

• The 76% of patients without baseline RPD enrolled in LEAD approximates incidence rates in prospective studies, thereby representing a large, clinically important group with no treatments currently approved

Patients without RPD at Baseline - Analysis

L E A D C L I N I C A L T R I A L : A S X E L X13

INTENT TO TREAT (ITT) PER PROTOCOL (PP)

Number at risk

Sham 110 108 102 96 95 90 88SNL 112 111 108 103 101 99 97

Time from baseline (months)

Cu

mu

lati

ve

pro

po

rtio

n

Adjusted HR: 0·23(95% CI 0·09–0·59)

Number at risk

Sham 35 35 35 32 32 30 29SNL 35 34 32 30 27 24 22

Time from baseline (months)

Cu

mu

lati

ve

pro

po

rtio

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Adjusted HR: 2·56(95% CI 0·80–8·18)

B Drusen With RPD at baseline

A Drusen Without RPD at baseline

SNLSham

• Increased rate of progression to late-stage AMD in the 2RT®

treatment group compared to the sham treatment group, although the treatment effect was not significant (p=0.112 for ITT and p=0.258 for PP analysis)

• Ellex 2RT’s mechanism of action requires the selective loss and subsequent healing of the RPE, there may be a stage of AMD disease whereby RPE integrity is so greatly compromised as to render treatment with Ellex 2RT® is unsuitable

• Such data is clinically valuable in selecting patients who are likely to respond to Ellex 2RT®

Patients with RPD at Baseline - Analysis

L E A D C L I N I C A L T R I A L : A S X E L X14

INTENT TO TREAT (ITT) PER PROTOCOL (PP)

• Though the primary endpoint across the entire study cohort was not met, Ellex 2RT®

displayed an exceptional safety profile

• Patients with no reticular pseudodrusen(RPD) deposits at baseline had a 77% reduction in the risk of progression to late stage AMD at any stage during the trial, which was conducted over three years

• This result is highly clinically meaningful and showed a remarkable treatment effect

LEAD Trial Conclusions

L E A D C L I N I C A L T R I A L : A S X E L X15

• RPD negative sub group represents approximately 75% of all iAMD patients with bilateral large drusen and no geographic atrophy

• LEAD was the first ever trial to show significant efficacy in an iAMD population

• Important new clinical information to guide retinal specialists in patient selection towards those without evidence of RPD

• Results are applicable only to Ellex 2RT® –authors discourage extrapolation of results to other thermal or non-thermal lasers

• Publication in Ophthalmology, the most important peer-reviewed ophthalmology journal globally, underscores the significance of the clinical results1

• Where Ellex 2RT® is approved for AMD, these markets represent an addressable market of 15 million patients per annum for screening and then treating those early stage patients without detectable RPD2

• Addressable market similar in size (patients) to late stage ‘wet’ AMD

• Ellex's commercialisation plan will be developed based on physician feedback, peer-to-peer educational programs focused on disease diagnosis, patient selection and treatment protocols

1 Guymer RH, et al. Sub-Threshold Nanosecond Laser Intervention in Age-Related Macular Degeneration: The LEAD Randomized Controlled Clinical Trial. Ophthalmol 2018; in press2 Marketscope Report August 2017 Ophthalmic Laser Report Table 2 "Global Forecast for AMD in all its Forms“, adjusted for Ellex estimates on RPD patients3 3m in the USA, 6m in China and 1m in Japan4 Age-Related Eye Disease Study Research Group. AREDS Report No. 8: A Randomized, Placebo-Controlled, Clinical Trial of High-Dose Supplementation With Vitamins C and E, Beta Carotene, and Zinc for Age-Related Macular Degeneration and Vision Loss. Archives of Ophthalmology 2001; 119 (10): 1417–1436. 5 Age-Related Eye Disease Study 2 Research Group. Lutein + zeaxanthin and omega-3 fatty acids for age-related macular degeneration: the Age-Related Eye Disease Study 2 (AREDS2) randomized clinical trial. JAMA. 2013 May 15:309(19):2005-15

Market Dynamics and Commercial Opportunity

L E A D C L I N I C A L T R I A L : A S X E L X16

• Future regulatory clearances in the US, Japan and China will increase the pool of treatable patients to 25 million per annum3

• No currently approved treatments for iAMD – only dietary and lifestyle modifications (a standard that resulted from analysis of the AREDS1 and AREDS2 studies4,5)

• Therapeutic approvals have been limited to late stage ‘wet’ AMD, which represents the minority of AMD patients

• Ellex intends to explore regulatory requirements for the US market

THANK YOU

L E A D C L I N I C A L T R I A L : A S X E L X17

Q/A SESSION

L E A D C L I N I C A L T R I A L : A S X E L X18